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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

MSF: Access to New TB Medicines Falters Despite Conditional Approvals

Doctors without Borders (MSF) released a new report on Monday offering details on how the first new drugs in nearly half a century were conditionally approved to treat tuberculosis (TB), though only 2% of the roughly 150,000 who could benefit from these treatments have access to them.

The report comes as the World Health Organization (WHO) reports that only half of notified multi-drug-resistant tuberculosis (MDR-TB) patients were successfully treated and cured in 2014 thanks to routine treatment.

“Encouragingly, early results from MSF and other implementers’ operational research in treating extensively drug-resistant (XDR) TB using the new drugs, bedaquiline and delamanid, in combination with promising repurposed drugs, indicate that much higher cure rates can be achieved than with existing regimens (culture conversion rates between 75% and 97% are seen, compared to 26% with existing regimens),” according to the new report.

Registration

WHO has called to incorporate bedaquiline and delamanid into the routine management of patients with DR-TB, but according to MSF, in order for this to become a reality: “The drugs need to be registered in country, with countries allowing import waivers in the meantime; countries need to update their treatment guidelines to reflect the WHO recommendations; adequate pharmacovigilance systems need to be introduced; and the accompanying drugs needed to form a regimen with the new drugs need to be affordable and available in country. These are not insurmountable hurdles and a number of countries are taking strides to ensure that patients have the opportunity to access the new drugs, particularly bedaquiline.”

Bedaquiline has been granted conditional or full marketing authorization by the National Medicine Regulatory Agency (NMRA), under the WHO, in nine of the 27 high MDR-TB burden countries, and submission is pending in nine others.

And for delamanid, the Japanese pharma manufacturer Otsuka has received conditional approval or full marketing authorization in Japan, South Korea, and in the EU from the European Medicines Agency, but delamanid is not registered in any high-burden countries, including four countries where Otsuka conducted clinical trials with the drug.

Pricing

The report also looks at the accessibility of three other drugs/combos: imipenem/cilastatin, clofazimine and linezolid, as well as details on the drugs’ price tags, which have gone down in recent years but still remain high.

“Recent reductions in the prices of most DR-TB drugs have brought preferred regimen prices down to a range of about $1,800-$4,600 per treatment course,” MSF said. “This is a marked improvement compared to our first Under the Microscope report in 2011, when drugs procured through the Green Light Committee (GLC)/ GDF cost between $4,400 and almost $9,000 per patient for a standard 18- 24 month treatment course. However, at up to $4,600 per treatment course, DR-TB treatment regimens are still unaffordable, limiting countries’ abilities to respond to the growing spread of drug resistance.”

“WHO and experts can contribute to smarter DR-TB markets by streamlining the number of second-line drug options recommended, in line with medical outcomes, so that the market isn’t unnecessarily split,” MSF says. “Data from ongoing and pending clinical trials should help inform decisions to cull certain drugs that have onerous side effects while offering little benefit to patients, and should help with fast-tracking other new and repurposed drugs that can improve patient outcomes…WHO and experts should also work with manufacturers to better forecast demand of streamlined drug options.”